Drug & medication recalls

Aurobindo Pharma Ltd. recalls Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc.…

Recall date
February 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0427-2018
FDA classification
Class III
Brand / firm
Aurobindo Pharma Ltd.
Sold / distributed
Nationwide within the US

Why it was recalled

Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.

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